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Biocides news

This page contains details of recent regulatory decisions and general news relating to the regulation of biocide products.

Information on significant historical regulatory decisions can be found in our archive.


UK position on the status under the Biocidal Products Regulation 528/2012 (BPR) of barley straw for the purposes of controlling blanket weed and other algae in lakes and ponds

Barley straw products have been marketed for the purposes of controlling blanket weed and other algae in lakes and ponds for some time. Barley straw is naturally occurring, and subject to ‘processing’ only so far as is necessary to harvest, chop and bag it before being sold for small-scale uses to treat e.g. fish tanks and ponds. The UK considers that barley straw is not a biocidal product under the EU Biocidal Products Regulations (BPR), and has gained support for that position.

The UK position is based on the definition in the BPR of “biocidal product” as a “substance” or a “mixture”. Given an interpretation of the EU REACH chemicals legislation by the European Chemicals Agency, the UK case is that barley straw is not a substance or mixture as defined, is out of scope of the BPR and does not need to be authorised to allow its continued use, for example to control algal growth in garden ponds.

HSE was considering seeking a formal decision under Article 3(3) of the BPR on the status of barley straw. We have revisited our position in the light of the Commission Implementing Decision (EU) 2016/678 of 29 April 2016 on dried lavender blossoms contained in a pad placed on the market to repel moths, that the product is neither a biocidal product nor a treated article for the purposes of Article 3(1)(a) and (l) of the Biocidal Products Regulation. Having consulted the EU Commission on how best to proceed, the UK considers that the recent decision on lavender blossom makes it clear that untreated Barley Straw is neither a biocidal product nor a treated article, on the same grounds as those set out for lavender blossom, and so is not in scope of the BPR. The UK will rely on this precedent to support its position, and so will not be submitting a request for a formal decision under Article 3(3) of the BPR. We have written in these terms to the other Member States setting out the UK position, copying it to the EU Commission.

These developments and the scenario above do not however extend to barley straw extract, as this does not meet the above conditions for unprocessed barley straw. Anyone wishing to support barley straw extract as an active substance or biocidal product will still need to provide the required data for evaluation.

Published 20 June 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for sodium p-chloro-m-cresolate for product types 1, 2, 3, 6, 9 and 13 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 25 May 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Published 20 June 2016


ECHA’s Biocides Stakeholders' Day

On 1 September 2016 the European Chemicals Agency (ECHA) will be holding their Biocides Stakeholders' Day in Helsinki. Companies unable to attend the event can follow the programme via a live web-stream.
Further details about the ECHA’s Biocides Stakeholders' Day, include information on accessing the live web-stream on the day, can be found on the ECHA website.

Please direct any questions about this event to ECHA not HSE.

Published 20 June 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for 6-(phthalimido)peroxyhexanoic acid (PAP) for product types 3 and 4

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 27 April 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website.

Published 2 June 2016


EU Biocides Regulation 528/2012 - Active Substance(s) Approval(s)

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

They will be approved for use in biocidal products placed on the EU market, on 1 October 2016. Biocidal products containing these active substance(s) will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 October 2016 in order to keep their biocidal products on the UK market after the active substance approval date, 1 October 2016. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 October 2016 for a biocidal product containing these active substance(s), the biocidal product shall no longer be made available on the UK market after 30 March 2017. Disposal and use of existing stocks of the biocidal product may continue until 1 October 2017. If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are effected by the approval of the above active substance(s).

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.

Published 19 May 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for pyridine-2-thiol 1-oxide, sodium salt (sodium pyrithione) for product type 3 and cetylpyridinium chloride for product type 2 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme,

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 25 February 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website.

Published 10 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – 1 September 2016 deadline for Treated Articles

Article 94 of EU Biocides Regulation (EU BPR) allows for treated articles to continue to be placed on the market until the approval for the relevant product type of the active substance(s) in the biocidal product the article was treated with or incorporates. If the active substance(s)/product type(s) combination is not already within the EU BPR review programme for the relevant product type, then an application for the approval of the active substance(s) for the relevant product-type has to be submitted to the European Chemicals Agency (ECHA) at the latest by 1 September 2016.

Interested parties need to submit a complete active substance dossier to ECHA through R4BP by 1 September 2016.

If an active substance is not supported by 1 September 2016 the treated articles must be removed from the market by 1 March 2017.

Published 10 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – 1 September 2016 deadline for In-Situ Generated Biocides newly under the scope of the EU BPR

Article 93 of the EU Biocides Regulation 528/2012 (EU BPR) outlines transitional provisions for biocides that weren’t regulated under the Biocidal Products Directive 98/8/EC (BPD) but are now regulated under the EU BPR. These transitional provisions apply to biocides generated in-situ from ambient precursors (e.g. air, seawater) and generated in-situ from general chemicals where they were not supplied with the intention that they were to be used to generate biocidal active substances.

If the precursor(s)/active substance(s)/product type(s) combination is not already within the EU BPR review programme for the relevant product type, then an application for the approval of the precursor(s)/active substance(s)/product type(s) combination has to be submitted to the European Chemicals Agency (ECHA) at the latest by 1 September 2016.

Interest parties need to submit a complete active substance dossier to ECHA through R4BP by 1 September 2016.

If a precursor(s)/active substance(s)/product type(s) combination isn’t supported by 1 September 2016 that precursor(s)/active substance(s)/product type(s) combination can no longer be used after 1 September 2017.

Further information about the requirements for in-situ generated biocides

Published 10 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – 1 September 2016 deadline for biocidal products that are newly within the scope of the EU BPR

Article 93 of the EU Biocides Regulation 528/2012 (EU BPR) outlines transitional provisions for biocides that weren’t regulated under the Biocidal Products Directive 98/8/EC (BPD) but are now regulated under the EU BPR. These transitional provisions apply to vermicides, working or cutting fluid preservatives (other than metal working fluid preservatives) and any other biocidal products that are newly within the scope of the EU BPR.

Interested parties need to submit a complete active substance dossier to ECHA through R4BP by 1 September 2016.

If an active substance is not supported by 1 September 2016 for the relevant product type the biocidal product must be removed from the market by 1 September 2017.

Further information about the requirements for newly within the scope biocidal products

Published 10 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – Active Substance Non-Approval Implementing Decisions

The following active substances have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR) and the EU Commission has decided not to approve them for use in biocidal product made available on the EU market.

It has also been decided not to approve

because all the participants have discontinued their participation from the biocides active substance review programme.

All affected companies are reminded that biocidal products containing these active substances, in the list product type,

Companies must manage the supply of the affected product to ensure there will be none remaining in the EU supply chain by 16 February 2017.

If the biocidal product was approval under the UK Control of Pesticides Regulations (COPR), affected companies will receive a certificate to revoke the COPR approval in line with the above dates.

Published 3 March 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for citric acid for product type 1 and chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification for product type 1 from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 9 February 2017. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Details of other open invitations where all participants have withdrawn their support or the active substance has been redefined can be found on the ECHA website

Published 3 March 2016


CLP Regulation – 9th Adaptation to Technical Progress (ATP) – effects on the supply and use of anti-coagulant rodenticides following revisions to nine harmonised classifications of active substances

Purpose

To alert interested stakeholders to the latest developments in the process to revise the harmonised classifications of nine active substances widely used in anti-coagulant rodenticides:

Background

A harmonised classification is the result of a decision on classification for a particular intrinsic hazard of a substance taken at EU level by ECHA’s independent Risk Assessment Committee (RAC). Harmonised classifications of substances are included in the Table 3.1 in Part 3 of Annex VI to the CLP Regulation (Classification, Labelling and Packaging of substances and mixtures). Harmonised classification applies to substances only.

The use of the harmonised classification and labelling of a substance (where one exists) is mandatory. It has to be applied by all suppliers of the same substance, i.e. by manufacturers of substances, importers of substances or mixtures, producers or importers of explosive articles, downstream users including formulators (producing mixtures) and distributors.

The proposals to revise the harmonised classifications to add the hazard class Toxic to Reproduction Cat 1A or 1B have been included in the 9th Adaptation to Technical Progress (ATP) to the CLP Regulation. The proposals were submitted by a number of Member States as part of the review programme under the Biocidal Products Regulation (BPR). Active substances are normally assigned a harmonised classification, agreed at European level (see CLP Article 36(2)).

The proposals reflect the opinion of ECHA’s independent Risk Assessment Committee (RAC) of all the available relevant scientific information, and were the subject of public consultation in March/April 2013. RAC’s published Opinions are based wholly on a careful consideration of relevant scientific data on the intrinsic hazard of the substances concerned. Socio-economic impacts do not form part of these considerations. These changes are not therefore unexpected and the process being followed is quite routine for classification purposes.

Compliance Date

A vote by Member States to adopt these changes is expected in February 2016, with the harmonised classifications expected to become mandatory from January/February 2018. Once adopted, the 9th ATP will be published as a European Commission Regulation which will update the list of harmonised classifications in Table 3.1 accordingly.

The BPR and CLP Competent Authorities at EU level are, however, aware of the impact of the decision to classify these nine active substances as Toxic to Reproduction, especially with respect to products containing them and approved for amateur use. The Toxic to Reproduction classification means approval for the amateur use of such products will be withdrawn.

Within the EU, to allow sufficient time for manufacturers/suppliers to make any changes to their products, both Competent Authorities have agreed to delay the mandatory compliance date for the harmonised classifications for the nine active substances listed above, and to permit products containing them to remain on the market until 30 June 2018.

For the UK, the requirements of the rodenticides stewardship regime set up by CRRU will apply. Under stewardship conditions, the use of non-stewardship labelled products will cease on 1 April 2017 (the end of December 2017 for farmers who are part of a farm assurance scheme as a transition measure). From that date, anyone seeking to access professional quantities of rodenticides in the UK will need to meet stewardship regime requirements, irrespective of the dates associated with the ATP.

Published 8 February 2016


EU Biocides Regulation 528/2012 - Active Substance(s) Approval(s)

The following active substance(s) have been evaluated under the EU Biocides Regulation 528/2012 (EU BPR):

They will be approved for use in biocidal products placed on the EU market, on 1 July 2016. Biocidal products containing these active substance(s) will therefore need to obtain EU BPR authorisation if they are to remain on the market.

All affected companies are reminded that they must apply for UK product authorisation by 1 July 2016 in order to keep their biocidal products on the UK market after the active substance approval date, 1 July 2016. Please note if your biocidal product contains more than one active substance the date by which you have to apply for product authorisation will be the date the last active substance in the product is approved.

If no application for product authorisation in the UK is made by 1 July 2016 for a biocidal product containing these active substance(s), the biocidal product shall no longer be made available on the UK market after 28 December 2016. Disposal and use of existing stocks of the biocidal product may continue until 1 July 2017. If the biocidal product has approval under the UK Control of Pesticides Regulations (COPR) its approval will be revoked.

Guidance for applying for product authorisation in the UK can be found in our EU BPR product authorisation section of the HSE biocides website. Guidance is also available there on the transitional arrangements for existing biocidal products on the UK market including products currently regulated under the COPR, which are affected by the approval of the above active substance(s).

The full Union list of approved biocidal active substances, including links to the approval decisions and assessment reports can be found on the ECHA website.

Published 8 February 2016


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following withdrawal of support for Didecyldimethylammonium chloride (DDAC (C8-10)) (product type 5), Performic acid generated from formic acid and hydrogen peroxide (product types 3, 5 and 6), Formic acid (product types 11 and 12) and Silver Copper Zeolite (product type 5) from the biocides active substance review programme

The following active substance/product type combinations are no longer considered to be supported in the biocides active substance review programme:

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 30 September 2016. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Published 16 November 2015


EU Biocides Regulation 528/2012 (EU BPR) – ECHA’s open invitations following redefinition of active substances in the biocides active substance review programme

Where the evaluation of an active substance demonstrates that it does not exactly match the identity of the substance as originally included in the Review Programme (Part 1 of Annex II of the biocides Review Regulation), the substance identity will be redefined by the evaluating competent authority (after consultation with the participant). It will be the redefined substance that will then go forward for Approval under the EU BPR, whilst for the ‘original’ substance an opportunity will be made for industry to come forward and take over the role of participant, and so support that ‘original’ substance through the review programme.

The following active substance/product type combinations originally included in the review programme have been so redefined and are therefore no longer considered to be supported in the biocides active substance review programme,

The European Chemicals Agency (ECHA) has published an open invitation, which allows interested companies to take over the role of participant for the above active substance/product type combinations.

Interested companies should complete the notification procedure in Article 17 of the Review Regulation by the 30 September 2016. Notifications should be submitted to the European Chemicals Agency (ECHA), via R4BP.

If no-one takes over the role of participant, these active substance/product type combinations will be subject to a non-approval decision and products containing them for the affected product types will have to be removed from the market.

Published 16 November 2015


Biocides Manual of Decisions (MoD) becomes obsolete - European Court of Justice decision on products with indirect effects on the target organism and scope of EU BPR - first step deadline 1 October 2016

Under the Biocidal Products Directive (BPD) where the scope of the legislation was unclear, issues were discussed at the EU level. When the EU Commission finalised decisions on scope issues, these are included in the BPD Manual of Decisions (MoD).

However as the EU Biocides Regulation (EU BPR) has repealed and replaced the BPD, the guidance provided in the MoD is now obsolete.

The EU Commission confirmed in their paper "New authoritative guidance in the meaning of Article 15 of Regulation (EU) No 1062/2014" that the MoD is obsolete as of 1 October 2015.

If you have relied on the guidance previously provided by the MoD to conclude that your product(s) were out of the scope of the biocides legislation, but your product might now be within the scope of the EU BPR, there is an opportunity to support the relevant active substance/product type combination. The EU Commission has specifically identified the issue of products that only work by indirect means on the target organism, which were previously considered to be outside the scope of the old BPD. Due to a decision by the European Court of Justice, that position has had to be reconsidered, and such products may now be within the scope of the EU BPR and therefore the active substances will need to be supported,  The EU Commission note provides information about the process to follow and further information on the European Court of Justice decision. Additional information on the declaration, notification, submission processes can be found on the European Chemicals Agency website. Please note the deadline for the first step in the process to support the relevant active substance/product type combination is 1 October 2016.

If you are unsure if your product now falls within the scope of the EU BPR please contact your National helpdesk or the ECHA helpdesk. Please note HSE are able to deal with enquiries that are relevant to our role as the UK Competent Authority (CA). If you do not have products on the UK market (or are not about to put them on the UK market) and you are based in another EU Member State (MS) we advise you to contact the CA in your MS.

Published 23 October 2015


Government agrees high level principles for stewardship regime for rodenticides - 23 July 2015

Pest rodents can threaten public and animal health and the UK infrastructure – controlling problem rodents is socially and economically important and, in some situations, may be required by law. A wide range of rodent control measures exist, including use of rodenticides (‘poisons’) which are valuable because they are effective and suitable for use in a variety of situations where other techniques would not work.

Regulatory environmental risk assessments have concluded that the use of First and Second Generation Anticoagulant Rodenticides (FGARs and SGARs) outdoors present a higher level of risk to non-target animals (such as predatory birds and mammals) than would normally be considered acceptable. As a result, outdoor use of these rodenticides would normally be banned. However the Government recognises that, despite carrying these risks, outdoor use of FGARs and SGARs is sometimes necessary as part of properly managed rodent control strategies.

In order to be able to authorise these rodenticides for use outdoors, the Government must be assured that the risks arising from such use will be properly managed. One way of providing that assurance is through a rodenticide stewardship regime. In April 2013, a Government Oversight Group, consisting of officials from HSE, HSE NI, DEFRA, Public Health England, Natural England, the Welsh and Scottish Governments and an independent scientific adviser, asked industry to explore ways to improve and spread good practice and to self-police professional use of FGARs and SGARs via an industry-led, voluntary ‘stewardship’ regime. The Government Oversight Group has agreed a set of high-level principles to assist industry in developing stewardship regimes. ( High-level principles for Rodenticide Regime(s) )

The new regime, managed by the Campaign for Responsible Rodenticide Use, will shortly be launched and will adhere to the high level principles. This will help to provide robust assurance that the continued use of FGARs and SGARs will use a hierarchy of risk controls for rodents, promoting responsible use and good practice by all suppliers and professional users.

High-level principles for Rodenticide Regime(s)

Any Rodenticide Stewardship Regime is built on:

Delivering key benefits such as:

Published 23 July 2015


Updated 2016-07-01